Using hypnotherapy to treat upper gastrointestinal symptoms
The Impact Of Gastric Phenotyping In Predicting And Assessing The Clinical Success Of Gut-Directed Hypnotherapy For Patients With Gastroduodenal DGBIS.
This study is testing if hypnotherapy can help people with upper gastrointestinal symptoms feel better compared to those who just receive educational information.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06846359 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of digitally delivered hypnotherapy sessions for patients experiencing upper gastrointestinal symptoms. Participants will be randomly assigned to either a hypnotherapy treatment group, receiving seven pre-recorded sessions over three months, or a control group receiving an educational module. The study will last for 24 weeks, including a 12-week treatment period followed by a 12-week follow-up, during which patients will complete electronic symptom questionnaires and undergo specific gastrointestinal tests. The aim is to determine if hypnotherapy can alleviate symptoms related to disorders of gut-brain interaction.
Who should consider this trial
Good fit: Ideal candidates are individuals with upper gastrointestinal disorders such as functional dyspepsia or nausea/vomiting disorders who have previously undergone gastric emptying tests.
Not a fit: Patients with untreated H. pylori infections or those who do not have access to digital devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option for patients suffering from upper GI symptoms.
How similar studies have performed: Other studies have shown promising results with hypnotherapy for gastrointestinal symptoms, indicating that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Patients will meet criteria for at least one upper GI DGBI including functional dyspepsia, any nausea/vomiting disorder, or functional abdominal bloating. Lower GI DGBIs, such as IBS, are allowable if the primary symptom is either an upper GI symptom or bloating/distension. * Participants will have had a negative 4-hour solid food gastric emptying test previously or a normal C13 Breath test at screening. * Patients with known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study. * Patients utilizing cannabinoid based substances may be included if no dose changes are made during the duration of the study * Patients will be proficient in English language for comprehension of content * Patients will have reliable access to digital delivery systems for content and questionnaire access via smartphone over the course of the study and follow up period. Exclusion criteria: * Patients with known current diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, advanced connective tissue diseases (e.g. scleroderma), and uncontrolled inflammatory bowel disease (IBD) will be excluded. * Patients with current untreated H. pylori infection will be excluded. * In patients with predominant bloating symptoms and constipation, those with untreated pelvic floor dysfunction will be excluded. If the predominant symptoms are nausea/vomiting or dyspepsia, or if constipation is not present, then pelvic floor dysfunction will not be exclusionary. * Patients who have a history of cognitive delay, traumatic brain injury with residual deficits, history of cerebral vascular accident with residual deficiencies in cognition, dementia, shall be excluded * Patients with significant psychiatric illness with component of psychosis (schizophrenia, bipolar disorder), as well as severe untreated major depressive disorder with suicidal ideation will be excluded * Patients with substance abuse disorders and drug addiction will be excluded. * Patients who are unlikely to comply or unlikely to benefit from psychotherapy-based interventions may be excluded at the direction of medical screening provider or principal investigator. * Standard inclusion criteria will include: ability to provide informed consent, absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results. * Stable doses medications are permissible, but dosing should not be changed during study period. * Patients who are pregnant.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Xiao Jing (Iris) Wang, M.D. — Mayo Clinic
- Study coordinator: Taylor Hines
- Email: Hines.taylor@mayo.edu
- Phone: 507-538-9959
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.